CompletedNot Applicable

LuCID - Investigating the Use of a Novel Digital Rectoscope for Community Examinations During COVID-19

United Kingdom114 participantsStarted 2020-11-14

Plain-language summary

The LumenEye scope and CHiP platform will be piloted in a number of clinical settings including remote colorectal clinics. The rationale is to perform an initial pilot study to determine the clinical utility of the LumenEye device for use in primary and secondary care settings. The main hypothesis is that digital rectoscopy is safe and acceptable to clinicians including general practitioners and can significantly reduce the burden of endoscopy referral to and within secondary care centres.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 18 and over * Patients with any of the following: * Positive Faecal occult blood test / Faecal immunochemical test (FIT) * Positive faecal calprotectin. * Established history of polyps and/or adenomas * 2WW patients referred to a colorectal clinic * Known IBD patients with flare symptoms * Patients with a suspected new diagnosis of IBD Exclusion Criteria: * Inability to consent * Inability to communicate effectively in English * Pregnancy * Unfit for bowel preparation * Anal stricture * Allergy to plastic * Inability to lie flat for more than 10 minutes

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient Experience of LumenEye Examination

Timeframe: On the day of examination

Clinician Experience of LumenEye Examination

Timeframe: On the day of examination

Trial details

NCT IDNCT05043363

SponsorImperial College London

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-06-05

Results submitted2022-08-04

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